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IRCT20170211032494N3 IRCT 2020-05-25 Tehran University of Medical Sciences Low dose whole lung irradiation for treatment of COVID-19 pneumonia Evaluation of low dose whole lung irradiation for treatment of resistant COVID-19 pneumonia 2020-05-27 anticipated 10 Complete https://irct.ir/trial/47735 interventional Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment, Other design features: In order to prevent the risks of disease spread, treatment will be taken on the last working shift of radiation oncology department on Wednesday evening and Thursday morning, when no other patient or personnel is in the working place. After the treatment session, all the treatment environment and its vicinity will be disinfected according to the standard guidelines for the next working shift on Saturday. 2 COVID-19 pneumonia. Intervention group: All patients will receive low dose whole lung irradiation for 100 Rads with 6 megavoltage photon beams in one session through two anteroposterior and posteroanterior fields by Varian linear accelerator radiotherapy device. Yes - There is a plan to make this available What will be shared: All collected Individual Participant Data (IPD) will be shareable after being anonymized When: Document files will become available indefinitely 2 months after publication of the results To whom: Researchers of academic institutions will be given access to the required data. Conditions: All types of analysis are permitted. All acquired data will be shareable if the requester is identified as an academic researcher by the study supervisor. Where to obtain: Data will be accessible through Dr Nima Mousavi Darzikolaee; Email: Mousavi.nima@yahoo.com/ mousavi-n@razi.tums.ac.ir How to obtain: The applicants should send an email to the provided email addresses indicating their scientific and academic identity, and declare where they will be using this data and for what intention, and state that their published work will cite the relevant researchers. In this case they will be able to obtain the relevant data files. Comments:
public Nima Mousavi Darzikolaee
Imam Khomeini Hospital Complex, Keshavarz Boulevard, Tehran
Tehran Iran (Islamic Republic of) 1419733141 +98 21 6694 8679 mousavi-n@razi.tums.ac.ir Tehran University of Medical Sciences scientific Nima Mousavi Darzikolaee
Imam Khomeini Hospital Complex, Keshavarz Boulevard, Tehran
Tehran Iran (Islamic Republic of) 1419733141 +98 21 6694 8679 mousavi-n@razi.tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) Diagnosis of COVID-19 by PCR or imaging Clinical symptoms of pneumonia or Acute Respiratory Distress Syndrome (coughing, dyspnea, need for supplemental oxygen) Obvious COVID-19 pulmonary patterns in chest CT scan Age over 60 Male gender Severe/refractory lung disease associated with COVID-19 Completion of written informed consent 60 years no limit Male Intubation Need for continuous NIV (Non-Invasive Ventilation) Need for CPAP (Continuous Positive Airway Pressure) Pulmonary disease due to non-COVID etiologies U07.1 COVID-19, virus identified Treatment - Other Intervention group: All patients will receive low dose whole lung irradiation for 100 Rads with 6 megavoltage photon beams in one session through two anteroposterior and posteroanterior fields by Varian linear accelerator radiotherapy device Blood pressure. Timepoint: Before intervention and every 6 hours after intervention. Method of measurement: Sphygmomanometer. Length of hospital stay. Timepoint: discharge date. Method of measurement: discharge date minus admission dates. CT score. Timepoint: 5 days after intervention. Method of measurement: Scores will range from 0-5 based on each lung lobe's percentile involvement as 0 for non-involvement, 1 for less than 5% involvement, 2 for 5-24% involvement, 3 for 25-49% involvement, 4 for 50-74% involvement and, 5 for 75-100% involvement, and the sum of each lobe score will be compared between the initial CT and the CT scan performed after discharge. Death. Timepoint: Until discharge. Method of measurement: Death verification. Pulse Rate. Timepoint: Before intervention and every 6 hours after intervention. Method of measurement: Pulse Oxymeter. Respiratory rate. Timepoint: Before intervention and every 6 hours after intervention. Method of measurement: Counting in one minute by physician. Body temperature. Timepoint: Before intervention and every 6 hours after intervention. Method of measurement: Thermometer. Oxygen saturation. Timepoint: Before intervention and every 6 hours after intervention. Method of measurement: Pulse oxymeter. SARS-CoV-2 Viral Load. Timepoint: Before the intervention and 4 days after the intervention. Method of measurement: SARS-CoV-2 Plasma PCR. Interleukin-6. Timepoint: Before the intervention and 48 hours after the intervention. Method of measurement: Interleukin-6 quantitative ELISA. Interleukin-1. Timepoint: Before the intervention and 48 hours after the intervention. Method of measurement: Interleukin-1 quantitative ELISA. Tehran University of Medical Sciences Approved 2020-05-13 Ethics Committee of Tehran University of Medical Sciences 6th floor, Vice Chancellor in Research Affairs, Central department of Tehran University of Medical Sciences, Qods Ave, Keshavarz Blvd Tehran Tehran Iran (Islamic Republic of)